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Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study (LIFT)

Primary Purpose

Senile Ptosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brow Lift
Sponsored by
Zift, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Senile Ptosis focused on measuring Brow Lift, Brow Ptosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Able to provide informed consent to the treatment
  2. Willing and able to participate in all the required follow-ups
  3. Over 18 years of age
  4. Under 75 years of age
  5. Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging

Exclusion Criteria:

  1. Known allergies to local anesthesia
  2. Currently undergoing chemotherapy or radiation therapy for cancer
  3. Known advanced osteoporosis that may lead to skull thinning
  4. Taking long-term immunosuppressant therapy
  5. Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment.
  6. Unable or unwilling to participate in follow-up examinations
  7. Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure)
  8. Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners
  9. Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology
  10. Treatment with neurotoxin in the past 6 months and during the study period. Subjects may undergo a neurotoxin washout for 6 months prior to study participation
  11. Planned surgical procedures, fillers or other facial procedures during the study period.
  12. Planned modification of the eyebrows (to include plucking or shaving) during the study period
  13. Planned MRI during the study period
  14. Known nickel allergy

Sites / Locations

  • Centennial Lakes Surgery Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZiftLift Tissue Anchor

Arm Description

Use of ZiftLift Tissue Anchors for Brow Lift

Outcomes

Primary Outcome Measures

Change in Brow Elevation
Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years

Secondary Outcome Measures

Patient Satisfaction
Patient Satisfaction using the Face-Q survey
Physician Satisfaction
Physician Satisfaction with Cosmetic Result. 7 metrics on all patients at all time points using a survey tool.

Full Information

First Posted
February 14, 2017
Last Updated
August 2, 2023
Sponsor
Zift, LLC
Collaborators
Libra Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03055819
Brief Title
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
Acronym
LIFT
Official Title
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Company no longer exists
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zift, LLC
Collaborators
Libra Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations
Detailed Description
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis. It is a single arm, open label multicenter study, to evaluate the safety and efficacy of the Zift Lift System. Up to 20 subjects in up to 3 sites will be enrolled in this study. Data from this trial will be used to confirm the device safety and efficacy and provide inputs to further refine the device design and procedure technique for future device iterations Subjects with signed informed consents and who meet all the inclusion and none of the exclusion criteria and are treated with the device will be considered enrolled in the study. An interim report will be created after the first 20 patients has completed their 90 follow up and the data monitored. The 20 patients, 90 day report may be submitted to FDA and other agencies for product clearance and registrations. After FDA clearance has been obtained, the study may be converted to a post-market study for the long term follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Senile Ptosis
Keywords
Brow Lift, Brow Ptosis

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, open label, multi-center
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZiftLift Tissue Anchor
Arm Type
Experimental
Arm Description
Use of ZiftLift Tissue Anchors for Brow Lift
Intervention Type
Device
Intervention Name(s)
Brow Lift
Other Intervention Name(s)
Brow Pexy
Intervention Description
Minimally Invasive Brow Lift
Primary Outcome Measure Information:
Title
Change in Brow Elevation
Description
Change in brow elevation in mm from baseline to 90 days, with long term follow-up out to 4 years
Time Frame
90 days, 6 months, 1, 2, 3 and 4 years
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient Satisfaction using the Face-Q survey
Time Frame
90 days, 6 months, 1, 2, 3 and 4 years
Title
Physician Satisfaction
Description
Physician Satisfaction with Cosmetic Result. 7 metrics on all patients at all time points using a survey tool.
Time Frame
90 days, 6 months, 1, 2, 3 and 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to provide informed consent to the treatment Willing and able to participate in all the required follow-ups Over 18 years of age Under 75 years of age Brow ptosis and/or functional limitations such as vision defects due to tissue laxity caused by aging Exclusion Criteria: Known allergies to local anesthesia Currently undergoing chemotherapy or radiation therapy for cancer Known advanced osteoporosis that may lead to skull thinning Taking long-term immunosuppressant therapy Taking chronic anticoagulation therapy (including ASA and NSAIDS) which can't be stopped for 10 days before treatment. Unable or unwilling to participate in follow-up examinations Evidence of brow soft tissue thickness less than 4mm by physical exam, ultrasound or direct probe (probe at the time of procedure) Stroke or TIE (Transient Ischemic Event) within the past 6 months and currently on anti-platelet or other blood thinners Chronic facial paralysis due to trauma, Bells Palsy, or similar etiology Treatment with neurotoxin in the past 6 months and during the study period. Subjects may undergo a neurotoxin washout for 6 months prior to study participation Planned surgical procedures, fillers or other facial procedures during the study period. Planned modification of the eyebrows (to include plucking or shaving) during the study period Planned MRI during the study period Known nickel allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Hilger, MD
Organizational Affiliation
Centennial Lakes Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centennial Lakes Surgery Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study

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